The comparison of the effects of piroxicam gel and oral vitamin E in treating cyclic breast pai

Phase 3

Completed

• Conditions: cyclic mastalgia; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12622000103763
• Lead Sponsor: Daniel F Fouladi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-07-12
• Study Start: 2022-01-24
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

Patients with cyclic mastalgia of grade 3 or more on visual analogue scale requiring treatment

Exclusion Criteria

-Pregnancy
-Concomitant or previous medical condition
-Irregular menses
-Presence of evidences indicating an underlying etiology for the breast pain by physical examination and/or in imaging studies
-Positive allergy to the used medications or placebos

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain assessed using a visual analogue scale (VAS)[1 month post-intervention commencement, 2 months post-intervention commencement (primary endpoint),]

Secondary Outcome Measures

Name	Time	Method
Side effects assessed in accordance with the Common Terminology Criteria for Adverse Events (CTCAE4).[1 month post-intervention commencement.]